New Option for Certain Patients with Resectable Non-Small Cell Lung Cancer

(BPT) - In 2018, Jenn Carroll, a human resources director from Connecticut, visited her doctor for what she thought was a routine exam. Although Jenn, a former smoker, was asymptomatic at the time of her allergist appointment, her doctor ordered a chest X-ray after Jenn asked about her allergy test results, specifically a result that suggested her lung capacity was that of an 80-year-old. She was 56 years old at that time. Upon referral, Jenn took the X-ray to a pulmonologist who confirmed through a biopsy that she had non-small cell lung cancer (NSCLC).

This finding led Jenn on a medical journey that was unexpected, yet not totally unsurprising. Lung cancer runs in her family.

“I can’t say that I was taken totally off guard by the news. Knowing my history, there was always in the back of my mind the chance that it could happen to me. Still, nothing really quite prepares you for hearing the news of a lung cancer diagnosis,” Jenn recalls. “Even though the diagnosis and all it was to entail was scary, I was at least fortunate that there were treatment options for my type of non-small cell lung cancer,” said Jenn.

Jenn first had a surgery to completely remove her tumor, and her surgeon discovered the cancer had spread to her lymph nodes – which changed her diagnosis to Stage IIB NSCLC. Jenn was lucky that she was diagnosed early. The following month, her doctor recommended that she receive chemotherapy. Unfortunately, people with Jenn’s type of cancer face a risk of the cancer returning even when it is found early and treated with the standard of care (surgery, sometimes followed by chemotherapy).

Three months after receiving four rounds of chemotherapy, Jenn’s doctor mentioned that she was a potential candidate for a clinical trial – the ADAURA Phase III trial – to test a new treatment regimen in patients with Stage IB-IIIA epidermal growth factor receptor mutation-positive (EGFRm) NSCLC who had surgery to completely remove the tumor. Jenn's Stage IIB NSCLC was found to have an EGFR mutation (exon 21 deletion), and therefore she was eligible to participate in the ADAURA trial. As part of the ADAURA trial, Jenn was given either osimertinib or placebo, and currently does not know which treatment she is receiving.

“I do sometimes worry about my cancer coming back but by continuing to participate in the trial, I have hope knowing that I am doing everything I can to give my disease a one-two punch,” Jenn said.

New Treatment Option May Decrease the Risk of Disease Recurrence

Based on the interim results of the ADAURA trial, the US Food and Drug Administration (FDA) approved TAGRISSO^® (osimertinib) for the treatment of adult patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) to help prevent lung cancer from coming back after removal by surgery.

Results from the ADAURA Phase III trial showed adjuvant treatment (i.e., after surgery) with TAGRISSO in patients with EGFR mutation-positive NSCLC reduced the risk of their cancer coming back or death:

• Primary Endpoint: In the ADAURA clinical trial, patients with Stage II and IIIA EGFRm NSCLC patients treated with TAGRISSO following surgery to completely remove their tumor were 83% less likely to experience their cancer coming back or death than with placebo
• Key Secondary Endpoint: Patients in the overall trial population (Stage IB, II and IIIA) treated with TAGRISSO following surgery were 80% less likely to experience their cancer coming back or death than with placebo
• The safety and tolerability of TAGRISSO in the ADAURA trial were consistent with the established safety profile. In the ADAURA trial, the most common adverse reactions (≥20%) were diarrhea, rash, changes in your nails, mouth sores, and dry skin. Please see the Important Safety Information for TAGRISSO below and a link to the complete Prescribing Information including Patient Information

This targeted adjuvant treatment regimen is offering new hope for resectable EGFRm NSCLC patients – potentially increasing the odds of disease-free survival (DFS) by lowering the risk of the cancer coming back or death. Before the FDA approval of TAGRISSO, there were no approved targeted treatments, given after surgery, that demonstrated improvement in DFS outcomes in EGFRm NSCLC following surgery.

“TAGRISSO given after surgery has the potential to change the way we treat NSCLC patients after surgery, giving them another option to treat their cancer if appropriate,” said Roy S. Herbst, MD, PhD, Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital. “Given in this post-surgical setting to patients diagnosed with EGFR mutation-positive NSCLC, TAGRISSO may help prevent the disease from coming back after surgery.”

Spotlighting the Importance of Diagnosing and Treating NSCLC Earlier

Just as each patient has a unique profile, so does each tumor. Tumors are driven by unique sets of genes that have their own mutations and alterations, called biomarkers. When doctors identify the specific thumbprint of a tumor, through biomarker testing, they can often prescribe medicines that are designed to target the tumor’s specific traits. Testing for biomarkers can be done by surgically removing a portion of the tumor during a biopsy.

TAGRISSO is designed to target a specific genetic mutation, called an EGFR mutation, which can be identified through this type of testing. Though biomarker testing is more commonly used as a standard of care when patients are diagnosed with metastatic (cancer that has spread to other parts of the body) NSCLC, the availability of TAGRISSO for EGFRm NSCLC patients after surgery emphasizes the importance of testing for EGFR mutations.

“I believe it is really important for others facing resectable non-small cell lung cancer (lung cancer that can be removed by surgery) to have their biomarker testing done for EGFR mutations as soon as they can,” Jenn said.

TAGRISSO IMPORTANT SAFETY INFORMATION

TAGRISSO may cause serious side effects, including:

• lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever
• heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your healthcare provider right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded
• eye problems. TAGRISSO may cause eye problems. Tell your healthcare provider right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO
• skin problems. TAGRISSO may cause skin problems. Tell your healthcare provider right away if you develop target lesions (skin reactions that look like rings), severe blistering or peeling of the skin
• inflammation of the blood vessels in your skin. TAGRISSO may cause blood vessel problems in your skin. Tell your healthcare provider right away if you develop purple spots or redness of the skin that does not fade in color when pressed (non-blanching) on your lower arms, lower legs, or buttocks or large hives on the main part of your body (trunk) that do not go away within 24 hours and look bruised

Before taking TAGRISSO, tell your healthcare provider about all of your medical conditions, including if you:

• have lung or breathing problems
• have heart problems, including a condition called long QTc syndrome
• have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
• have a history of eye problems
• are pregnant or plan to become pregnant. TAGRISSO can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant
  • Females who are able to become pregnant should have a pregnancy test before starting treatment with TAGRISSO. You should use effective birth control during treatment with TAGRISSO and for 6 weeks after the final dose of TAGRISSO
  • Males who have female partners that are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 4 months after the final dose of TAGRISSO
• are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during treatment with TAGRISSO and for 2 weeks after your final dose of TAGRISSO. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your healthcare provider if you take a heart or blood pressure medicine

The most common side effects of TAGRISSO are:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TAGRISSO. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is TAGRISSO?

TAGRISSO is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has certain abnormal epidermal growth factor receptor (EGFR) gene(s):

• to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery, or
• as your first treatment when your lung cancer has spread to other parts of the body (metastatic), or
• when your lung cancer has spread to other parts of the body (metastatic) and you have had previous treatment with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working

Your healthcare provider will perform a test to make sure that TAGRISSO is right for you.

It is not known if TAGRISSO is safe and effective in children.

Please see complete Prescribing Information, including Patient Information.

©2020 AstraZeneca. All rights reserved. US-43140 Last Updated 12/20